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NCT Number: NCT04459234

Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation…) and administration protocol (route, posology, duration, administration sequence, premedication).

The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression.

In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Bergonié, Bordeaux, France

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About this study

Almost 382,000 new cancers have been diagnosed in France in 2018. Regular progresses in their management have improved the overall survival of patients, sometimes with sequelae that may be particularly painful. Thus for 20 to 45% of patients treated for breast cancer, pain persists 5 years later.

If remission is a regularly reached target, cancer was also the cause of 157,000 deaths in 2018 in France, preceded by months or years of progression of a chronic disease that regularly causes pain. Pain during cancer (chronic cancer pain for CIM-11) remains a frequent symptom, and its prevalence has slightly changed during the last 20 years.

In the European EPIC study, carried out in 2006, 76% of the cancer patients (and 62% of French patients) presented moderate to severe pains linked to cancer, daily for more than half of them.

Even when identified, chronic cancer pain is still under-treated in 25 to 60% of cases worldwide, including in the most developed countries.

When well-managed, pain's management now allows the relief of almost 80% of patients. Pain's management is based in particular on a precise and adapted use of the different opioids through different routes of administration (oral, transdermal, trans-mucosal, parenteral, etc.).

A neuropathic component of pain exists in almost a third of cases and may require specific treatments when opioids are insufficient. In all cases, the treatment is integrated into a multidisciplinary management, in connection with the ongoing oncological treatments, the loco-regional treatments available (radiotherapy, interventional radiology, etc.) and with an adapted psychosocial management.

Ketamine is an NMDA receptor antagonist (N-Methyl-D-Aspartate) indicated as a high dose anesthetic. It is used in the context of peri-operative pain for its anti-hyperalgesic properties. These properties have led to its use also in palliative care (outside the marketing authorization [AMM]) to treat hyperalgesia linked to the use of high-doses of opioids, as well as depression. For non-cancer pains, ketamine is widely used by centres and consultations specialized in refractory chronic pain management in different pains not relieved by standard treatments: neuropathic pain, fibromyalgia, etc., or even in opioids weaning aid.

The bibliographic data are not homogeneous and of low quality. Despite the weakness of the available data, ketamine is widely used in France in chronic pain in situation of therapeutic impasse. The protocols used vary according to the prescribers and services practices: venous route in general, sometimes subcutaneous or even oral; doses varying from 30 to 200 mg / day, infusion duration varying from a few hours to several days, discontinuous administration by cycle or continuous administration, etc.

Current knowledge is too limited in oncology to have a consensus on the use of ketamine :

  • Often retrospective studies with heterogeneous treatment protocols;
  • Studied populations also heterogeneous, with insufficiently documented indications;
  • Staff not able to answer adequately the questions raised. This situation largely explains the heterogeneity of the Ketamine practices of use in oncology

It is essential to draw up an inventory of the ketamine use by the French CLCCs pain teams and to identify the profile of patients in whom i) the treatment is ineffective and must be avoided regarding toxicities ii) the potential efficacy required further investigations. Built on a methodology close to the OKAPI study, the KETACANCER study will enable to compare indirectly the results of the two studies.

To do this, it is proposed to conduct the KETACANCER prospective study in a precise population defined a priori, and corresponding to the following indications:

  • Neuropathic sequelae pain
  • Additional effect of morphine
  • Morphine weaning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient at least 18 years old at the day of consenting to the study
  • Patient followed for a solid tumour or a hematological malignancy (treated or under treatment)
  • Patient presenting cancer chronic pain or post cancer treatment pain
  • Patient followed by a CLCC's intractable chronic pain consultation or centre
  • Patient with an indication of 1st Ketamine course:
  • Analgesic treatment of cancer chronic pain
  • Analgesic treatment for a post-cancer treatment chronic pain
  • Help for withdrawal from opioid treatment prescribed for a chronic cancer pain
  • Patient not previously treated by Ketamine
  • Patient covered by a medical insurance
  • Patient and/or family did not decline data collection after complete information (information sheet)

Exclusion criteria

  • Patient presenting chronic pains not related to cancer or its treatments
  • Patient with a proven psychotic history
  • Patient who is not fluent enough in French

Treatment and study plan

Ketamine use in CLCC sites (indication and administration protocol)

Drug

Collection of information concerning Ketamine use by French CLCCs pain teams (first prescription):

  • Indications : analgesic treatment of cancer chronic pain, analgesic treatment for a post-cancer treatment chronic pain, help for withdrawal from opioid treatment prescribed for a chronic cancer pain
  • Administration protocol: route, posology, duration, administration sequence, premedication
  • Antalgic efficacy
  • Tolerance profile
  • Quality of life, anxiety and depression evaluations

Primary outcomes

  1. Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication

    Time frame: Up to 3 months after inclusion

    neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation

  2. Describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of administration protocol

    Time frame: Up to 3 months after inclusion

    route, posology, duration, administration sequence, premedication

Secondary outcomes

  1. Evaluate in the context of cancer the antalgic efficacy

    Time frame: Up to 3 months after inclusion

    Questionnaire: NPSI

  2. Evaluate in the context of cancer the antalgic efficacy

    Time frame: Up to 3 months after inclusion

    Questionnaire: DN4

  3. Evaluate in the context of cancer the antalgic efficacy

    Time frame: Up to 3 months after inclusion

    Questionnaire: PGIC

  4. Evaluate in the context of cancer the tolerance profile

    Time frame: Up to 3 months after inclusion

    The safety will be described mainly on the frequency of adverse events coded using the common toxicity criteria (NCI-CTCAE v5.0) grade. Descriptive statistics will be provided for characterizing and assessing patient's tolerance to treatment. Adverse events will be coded according to the MedDRA®.

  5. Evaluate in the context of cancer the quality of life including anxiety and depression

    Time frame: Up to 3 months after inclusion

    Numeric scale (from 0 : no pain to 10: maximum pain)

  6. Evaluate in the context of cancer the quality of life including anxiety and depression

    Time frame: Up to 3 months after inclusion

    Questionnaire: HADS

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC

Acronym: KETACANCER

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
Sep 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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